MAUDE Adverse Event Report: CONMED CONMED; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	AES-30
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported on behalf of a customer that the aes-30, arthroscopic energy 30° probe, 8.5 cm device was used in a wrist arthroscopy procedure on (b)(6) 2026, and ¿the surgeon inserts the device into the joint; however, when performing a lever-type motion, he slightly bends the radiofrequency tip, which becomes lodged inside the patient while attempting coagulation.¿.The procedure was completed with the use of an alternate same device.A good faith effort was made to obtain additional information, but no response has been received to date; however, photographs provided demonstrate the retrieval of the device tip.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The reported device has been returned to conmed; however, the complaint investigation has not been completed.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: CONMED
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 24969517
• Report Number: 1320894-2026-00108
• Device Sequence Number: 10580438
• Product Code: GEI
• UDI-Device Identifier: 30653405064149
• UDI-Public: (01)30653405064149(17)280329(10)202303311
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K140578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AES-30
• Device Lot Number: 202303311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Sex: Male